Pregnancy Limited human data on use in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage Verify pregnancy status of females of reproductive potential before starting treatment Animal data Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus In animal embryofetal development studies, oral upadacitinib administration to pregnant rats and rabbits at exposures greater or equal than ~1.6 and 15 times the maximum recommended human dose (MRHD), respectively, resulted in dose-related increases in skeletal malformations (rats only), an increased incidence of cardiovascular malformations (rabbits only), increased postimplantation loss...